Salmeterol powder provides significantly better benefit than montelukast in asthmatic patients receiving concomitant inhaled corticosteroid therapy

Study objectives: Comparison of inhaled salmeterol powder vs oral monteluka st treatment in patients with persistent asthma who remained symptomatic wh ile receiving inhaled corticosteroids. Design; Randomized, double-blind, double-dummy, parallel-group, multicenter trials of 12-week duration. Setting: Outpatients in private and university-affiliated clinics. Patients: Male and female patients greater than or equal to 15 years of age with a diagnosis of asthma (baseline FEV1 of 50 to 80% of predicted) and s ymptomatic despite receiving inhaled corticosteroids. Interventions: Inhaled salmeterol xinafoate powder, 50 mug bid, or oral mon telukast, 10 mg qd. Measurements and results: Treatment with salmeterol powder resulted in sign ificantly greater improvements from baseline compared with montelukast for most efficacy measurements, including morning peak expiratory flow (35.0 L/ min vs 21.7 L/min; p < 0.001), percentage of symptom-free days (24% vs 16%; p < 0.001), and the percentage of rescue-free days (27% vs 20%; p = 0.002) . Total supplemental albuterol use was decreased significantly more in the salmeterol group compared with the montelukast group (- 1.90 puffs per day vs - 1.66 puffs per day; p = 0.004) and nighttime awakenings per week decre ased significantly more with salmeterol than with montelukast (- 1.42 vs - 1.32; p = 0.015). Patients treated with inhaled salmeterol were significant ly more satisfied with their treatment regimen and how well, how fast, and how long it worked than were patients who were treated with oral montelukas t. The safety profiles for the two treatments were similar. Conclusion: In patients with persistent asthma who remain symptomatic while receiving inhaled corticosteroids, adding inhaled salmeterol powder provid ed significantly greater improvement in lung function and asthma symptoms a nd was preferred by patients over oral montelukast.